Phase 1 Study of Belimumab in Subjects With Systemic Lupus Erythematosus (SLE)

PHASE1CompletedINTERVENTIONAL
Enrollment

70

Participants

Timeline

Start Date

February 28, 2002

Primary Completion Date

March 31, 2003

Study Completion Date

March 31, 2003

Conditions
Systemic Lupus Erythematosus
Interventions
BIOLOGICAL

belimumab

"1. 1 mg/kg, IV (in the vein) once on Day 0, with a final evaluation at Day 84 (Cohort 1).~2. 1 mg/kg, IV (in the vein) on Days 0 and 21, with a final evaluation at Day 105 (Cohort 5)."

BIOLOGICAL

belimumab

"1. 4 mg/kg, IV (in the vein) once on Day 0, with a final evaluation at Day 84 (Cohort 2).~2. 4 mg/kg, IV (in the vein) on Days 0 and 21, with a final evaluation at Day 105 (Cohort 6)."

BIOLOGICAL

belimumab

"1. 10 mg/kg, IV (in the vein) once on Day 0, with a final evaluation at Day 84 (Cohort 3).~2. 10 mg/kg, IV (in the vein) on Days 0 and 21, with a final evaluation at Day 105 (Cohort 7)."

BIOLOGICAL

belimumab

"1. 20 mg/kg, IV (in the vein) once on Day 0, with a final evaluation at Day 84 (Cohort 4).~2. 20 mg/kg, IV (in the vein) on Days 0 and 21, with a final evaluation at Day 105 (Cohort 8)."

BIOLOGICAL

Placebo

"1. IV (in the vein) on Day 0 (Cohorts 1-4).~2. IV (in the vein) on Days 0 and 21 (Cohorts 5-8)."

Trial Locations (18)

10003

Hospital for Joint Diseases, New York

11030

North Shore University Hospital, Manhasset

11203

SUNY Downstate Medical Center, Brooklyn

15261

University of Pittsburgh School of Medicine, Pittsburgh

20010

Washington Hospital Center, Washington D.C.

27157

Wake Forest University School of Medicine, Winston-Salem

27599

The University of North Carolina at Chapel Hill, Chapel Hill

27710

Duke University, Durham

29425

Medical University of South Carolina, Charleston

35294

University of Alabama at Birmingham, Birmingham

48109

The University of Michigan Health System, Ann Arbor

60611

Northwestern University Medical School, Chicago

60612

Rush-Presbyterian-St Luke's Medical Center, Chicago

60637

The University of Chicago Hospital, Chicago

73104

Oklahoma Medical Research Foundation, Oklahoma City

75390

University of Texas Southwestern Medical Center at Dallas, Dallas

90033

University of Southern California, Los Angeles

90095

University of California-Los Angeles, Los Angeles

Sponsors
All Listed Sponsors
lead

Human Genome Sciences Inc.

INDUSTRY